Status:
COMPLETED
Safety and Efficacy of AL-53817 Nasal Spray Solution
Lead Sponsor:
Alcon Research
Conditions:
Nasal Allergies
Allergies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study was to determine the maximum tolerated dose of AL-53817 (Stage A) and evaluate the safety and efficacy of AL-53817 for the treatment of allergic rhinitis (Stage B).
Detailed Description
Stage A was a 1-day, single ascending dose study utilizing 7 separate cohorts of unique subjects (healthy normal volunteers). Each cohort was administered a different dose of AL-53817 Nasal Spray Solu...
Eligibility Criteria
Inclusion
- Stage A
- Willing and able to give written informed consent.
- In good health in the opinion of an appropriately qualified physician.
- Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have a negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
- Other protocol-defined inclusion criteria may apply.
- Stage B
- History of non-recalcitrant seasonal allergic rhinitis during the fall allergy season.
- Allergy to short ragweed allergen, defined by positive skin prick test for short ragweed allergen within the 12 months prior to Visit 1.
- Be in good health in the opinion of an appropriately qualified physician.
- Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
- Other protocol-defined inclusion criteria may apply.
- Stage A
Exclusion
- Hypersensitivity to the study drug or any component of the test articles, including benzalkonium chloride.
- Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of \< 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
- Current or recent history of severe, unstable, or uncontrolled conditions based upon a review of medical history and/or physical examination.
- Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
- History of HIV, hepatitis B or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
- Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
- Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
- Other protocol-defined exclusion criteria may apply.
- Stage B
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01454505
Start Date
October 1 2011
End Date
March 1 2012
Last Update
May 20 2013
Active Locations (1)
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1
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134